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FDA Approves Ovcon 35 as the First Chewable Oral Contraceptive Tablet for Women

The FDA has approved Ovcon 35, an oral spearmint-flavored contraceptive tablet that can be chewed and swallowed. This new version of Ovcon 35, indicated for the prevention of pregnancy, provides one more alternative to the many types of oral contraceptives currently on the market. Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol) found in products already marketed.

The directions for use tell women that the pill may be swallowed whole or chewed and swallowed. If the pill is chewed and then swallowed, the woman should drink a full 8-oz glass of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.

Ovcon 35 is available only in a 28-day regimen. Each package contains 21 round, white tablets, with norethindrone and ethinyl estradiol followed by seven reminder green (inactive) tablets to complete a 4-week-cycle.

Like other birth control pills, Ovcon 35 is effective for prevention of pregnancy when used as directed. The risks of using this product are similar to those of all birth control pills and include an increased risk of blood clots, heart attack, and stroke. The labeling also carries the warning that cigarette smoking by women, especially over age 35 increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.

The product is manufactured by Bristol Myers Squibb Company, Princeton, N.J., and will be marketed by Warner Chilcott, Inc., Rockaway, N.J.

Chewable Birth Control Pill Launched in U.S.

The first chewable birth control tablet in the United States was officially launched Thursday by drug maker Warner Chilcott.

The company says that Femcon Fe provides an option for women who don't like swallowing pills and want to carry their birth control with them. The chewable tablet, which is aimed at women who occasionally forget to take their pills, contains the same hormones as standard oral contraceptives, the Associated Press reported.

Femcon Fe is packaged in the typical 28-day cycle -- 21 days of active pills and seven days of inactive pills. Women must drink 8 ounces of water when taking a tablet. A month's supply will sell for $44 wholesale. The price will be slightly more at pharmacies.

The spearmint-flavored tablet can also be swallowed without chewing.

"This isn't a great leap forward, but I think this is a helpful step," Dr. Lee Shulman, chairman of the Association of Reproductive Health Professionals, told the AP.

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